Dec. 23, 2024—Mainz Biomed announced an agreement with Quest Diagnostics to support commercialization of the company’s next-generation screening test for colorectal cancer, ColoAlert. Quest will provide clinical trial laboratory services for Mainz Biomed’s ReconAAsense study, a prospective clinical study that will include approximately 15,000 subjects from 150 sites across the United States to develop data supporting FDA validation of the next-gen test. Mainz Biomed will provide Quest with the option to exercise semi-exclusive rights to provide testing services based on the test kit for an 18-month period, assuming the test’s approval by the FDA.
Mainz Biomed’s stool-based ColoAlert test is designed to detect colorectal cancer tumor DNA to aid in identifying colorectal cancer in early stages.